various irrigat ion methods), basal trunk spray, and tree trunk injection. EFED has

conducted a Section 3 New Use assessment and has determined the following.

Summary of Risk conclusions

a. Foliar, Airblast & Broadcast spray application , soil application (i.e., soil

medi a drench, chemigation), basal trunk spray application

These particular application types (ground/aerial spray, soil incorporation) and/or maximum application rates (0.54 lbs a.i./A) are found in the 2004 risk assessments (DP Barcodes: D285633, D304957) w ith use on ornament al plants , which are listed on the current label in conjunction with the proposed forestry uses

. The risk conclusions

described for the 2004 assessments apply to the proposed uses as well.

b. Tree injection

Overall, the screening level a nalysis conducted for the tree injection use pattern, which assumes total mass of chemical applied to the terrestrial and aquatic environments as well as distribution of concentrations in tree trunks and leaves, suggests that translocation of

dinotefuran f

rom the site of injection to edible portions of a tree may result in effects to birds, mammals, and terrestrial invertebrates . Potential risks to saltwater invertebrates could not be precluded given the sensitivity of the mysid shrimp to relatively low

con centrations of dinotefuran

. Additional data, including a chronic study on the saltwater invertebrate, magnitude of residues study in injected trees and treated plants, and an additional bee field study would allow for refinements of potential risks.

Ris k calculations could be refined further should a limit on use of dinotefuran for the tree injection use pattern be proposed , either as a limit to application rate (lbs a.i./A) or application target (number of trees of a given size/A). Given the high toxici ty of dinotefuran to honeybees on an acute oral and contact basis, other terrestrial invertebrates on a contact basis, and the lack of information on the magnitude of residues on edible parts of potentially treated trees as well as toxic effects on honey b ee colonies, the re is

concern about the magnitude of exposure and potential effect on honey bee colonies This mitigation measure would limit the use of dinotefuran on a per acre basis and thus limit visitation potential of the bee or other pollinator /forag er species to contaminated trees (i.e. for any given acre it could poten tially visit to retrieve pollen and/or n ectar the ratio

of contaminated to untreated trees is lower, providing the pollinator with more alternatives for 'safer' forage).

Label recomme ndations

EFED recommends the following statements and clarifications be incorporated in the proposed label for Dinotefuran 20%, EPA Reg No. 86203

- 11:1. Include a statement clarifying application timing. For example: “for trees pollinated by bees or other i nvertebrates, make applications post

- bloom.” It is understandable that applications post

- bloom for certain application types may be difficult for some forestry uses as non

- target organisms may be in bloom while target organisms have reached the post

- bloom period. However, i t must be clear

from the label that application of dinotefuran to blooming, pollen

- shedding or

nectar

- producing parts of plants should be avoided . Currently, application timing is based on pest life cycle and the hazard statement for bee s does not specify when to apply; the current hazard statement is as follows: “The product is highly toxic to bees exposed to direct treatment or residues on blooming crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds if bees are visiting the treatment area.”

2. Include a statement relating the expected duration of pest control post

- injection. For example: “Dinotefuran 20% provides 1

- 2 years of residual control of given pest.” As the 1

- 2 years is only an estimate based on expected levels for imidacloprid (e.g., IMA

-

jet label, 5% a.i. Reg. No. 74578

- 1 by Arborjet, Inc.), the registrant is advised to provide the study specific for dinotefuran indicating muti

year persistence in trees and justification for the actual timefr ame expected for pest control duration.

3. Clarify what the substance of formulation is: a water soluble granule (SG), an emulsifiable concentrate (EC), wettable powder or liquid.

4. Confirm retreatment interval for soil applications (including chemigation) i s 7 days. The retreatment intervals should be clearly stated for each use pattern.

Data gaps

Fate Studies

835.4100 Aerobic Soil Metabolism (MRID#s 45640111 and #45640112). These two studies were found to be supplemental. One of the studies (#45640111 ) was conducted as a preliminary study and many details of the study methods were not reported. In addition, the study was terminated after only 90 days. The other study (#45640112) did not satisfy the guideline requirement for an aerobic soil biotransfo rmation because the extraction methods failed to extract a significant fraction of the identifiable [14C]residues, including dinotefuran, from the soil. None of these supplemental studies provided any data on the degradation rate of the major transformati on products of dinotefuran. The combined studies provide sufficient data to determine the rate of degradation of dinotefuran, but neither study provides information about the fate of the major transformation products of dinotefuran. This study (MRID#456401 12) can be upgraded if the registrant addresses the characterization of the major degradates at various sampling intervals. Otherwise, a new study is required to fully address the data requirement.Ecotox Studies

OPPTS 850.1350 Mysid Chronic Toxicity Te st
Since estuarine/marine chronic toxicity studies were not submitted for this compound there is an uncertainty regarding chronic risk to estuarine/marine fish and invertebrates. However, given that dinotefuran technical is highly toxic to mysid shrimp ( i. e. , <1 mg a.i./L) on an acute basis (MRID 45639713) and the hydrolysis half

- life (MRID 45640101) of dinotefuran indicates that the parent is stable in water at pH 4

- 7 and is ~48 days at pH 9, a mysid chronic toxicity study is required under 40 CFR §158.

N on

- Guideline Magnitude of Residues Study: Field Residue Analysis of Edible Parts of Trees/Plants (Whole flowers, Leaves, Fruit, Seeds, Pollen, and Nectar [from flowers and, if present, extrafloral nectaries]) Submission of a magnitude of residues study tha t quantifies potential exposure levels after tree injection and other application types would be of high value to this risk assessment. Risks may be further quantified and refined if a magnitude of residues study

in treated trees and plants is submitted t hat evaluates concentrations of dinotefuran in edible parts of treated trees and plants, including leaves, fruit, s eeds as well as blooming, pollen

- shedding, and nectar producing parts ( i.e. , flowers and, if present, extrafloral nectaries) of plants. The r eason for asking for multiple test species and plant part residues stems from open literature data available for imidacloprid, another systemic

neonicotinoid. The studies reveal that imidacloprid will move into the plant parts at

different concentrations b ased on the type of plant ( i.e.

, corn pollen will have different concentrations of imidacloprid compared to sunflower pollen) and the part of the plant ( i.e.

, pollen will have different concentrations of imidacloprid compared to nectar). In addition, given that there is no information on rate of degradation of dinotefuran inside the plant, concentrations of degradates of dinotefuran in these plant parts would also be of high value to this risk assessment. Therefore, the EFED concludes that information on

di notefuran/degradate concentrations, in various plant parts for different crops is essential

to und erstanding the potential exposure levels of dinotefuran and degradates to terrestrial

non

- target invertebrates , mammals, and birds over time

. A study protocol should be submitted for Agency review prior to study initiation.

OPPTS 850.3040 Field Testing for Pollinators A new honey bee field study that provides relevant and reliable toxicity information on the performance of the colonies after exposure to dino tefuran is recommended. A study protocol should be submitted for Agency review prior to study initiation.

Dinotefuran is highly toxic to bees on an acute oral and contact basis and when applied as a foliar spray at a rate of 0.13 lbs a.i./A it will remai n toxic to bees on foliage for more than 24 hours after application (MRID 45639728). Because of this, EFED recommends that dinotefuran not be applied to blooming, pollen

- shedding or nectar

- producing parts of plants; but the test crop should be one on which bees will actively forage for both nectar and pollen (e.g., cotton, melon, alfalfa). EFED expects the study design will includemaximum dinotefuran application rates, at minimum intervals, and maximum number of

applications. EFED does not know how much di notefuran can be expected to be translocated to the nectar and pollen when applied as a foliar, soil, or tree injection application to plants before nectar or pollen production. Though the currently reviewed field study had detected residues in pollen and nectar of flowers after foliar application, the study design was such that toxicity endpoints could not be reliably determined. If dinotefuran is being translocated to the nectar and pollen, there is uncertainty as to whether there is any adverse effect to foragers or to the hive over time.